A Study of Carbon 13-based Deep Labelling of Bone Marrow Cells

NCT ID: NCT07057583

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-12-31

Brief Summary

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This study evaluates a novel laboratory method to study how certain bone marrow cells in the body take up nutrients from their environment.

Detailed Description

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PRIMARY OBJECTIVE:

I. Evaluate differences in the amount of extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs).

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

GROUP I: Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study.

GROUP II: Healthy volunteers undergo blood collection and bone marrow aspiration on study.

Conditions

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Monoclonal Gammopathy of Undetermined Significance (MGUS) Non-IgM Monoclonal Gammopathy of Undetermined Significance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational Group I

Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Observational Group II

Healthy volunteers undergo blood collection and bone marrow aspiration on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All Participants:

* At least age 18 years or older
* Able to provide informed consent
* MGUS Cohort:

* International Myeloma Working Group (IMWG) criteria for the diagnosis of non-IgM MGUS

Exclusion Criteria

* All Participants:

* Unable to provide consent
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \>1
* Prior history of adverse events with conscious sedation
* Ongoing use of immunosuppressive medications
* All known pregnant and lactating women will be excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wilson I. Gonsalves, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2025-01095

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-003478

Identifier Type: OTHER

Identifier Source: secondary_id

HT9425-24-1-0619

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-003478

Identifier Type: -

Identifier Source: org_study_id